The Withdrawn ASR™ THA and Hip Resurfacing Systems: How Have Our Patients Fared Over 1 to 6 Years?
Rent the article at a discountRent now
* Final gross prices may vary according to local VAT.Get Access
The Articular Surface Replacement™ (ASR™) metal-on-metal hip arthroplasty system (DePuy Orthopaedics, Inc, Warsaw, IN, USA) reportedly has a higher than anticipated early failure rate leading to a voluntary recall. This prompted us to evaluate all ASR™ components implanted at our center.
In all ASR™ components, we reported (1) revision rate, (2) blood metal ion levels, and (3) intraoperative findings for revisions related to adverse reaction to metal debris (ARMD).
We retrospectively reviewed all 172 patients (190 hips) who underwent THA (149 hips) or hip resurfacing (41 hips) with the ASR™ system. We determined failure rates. We obtained blood metal ion concentrations from 93 patients at last followup. We evaluated MRI studies and intraoperative histopathology. Minimum followup was 12 months (mean, 40 months; range, 12–74 months).
At latest followup, we had revised 24 of 190 hips (13%): in 18 patients with THA and five patients with resurfacing. Mean time to revision was 45 months (range, 12–75 months). Mean blood concentrations were 13 μg/L (range, 0–150 μg/L) for cobalt and 6 μg/L (range, 0–87 μg/L) for chromium. Mean prerevision blood metal ion levels were higher in the revised group (cobalt: 48 μg/L; chromium: 18 μg/L) than in the nonrevised group (cobalt: 5 μg/L; chromium: 2 μg/L). ARMD was present in 14 of the 24 hips revised in this study.
Surgeons must have a low threshold for concern for ARMD in patients with ASR™ systems. Blood metal ion levels and MRI can be used to evaluate patients with underperforming implants. Intraoperative histopathologic analysis and joint fluid cytology can help diagnose ARMD at the time of revision.
Level of Evidence
Level III, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.
- Bernthal NM, Celestre PC, Stavrakis AI, Ludington JC, Oakes DA. Disappointing short-term results with the DePuy ASR XL metal-on-metal total hip arthroplasty. J Arthroplasty. 2012;27:539–544. CrossRef
- Bolland BJ, Culliford DJ, Langton DJ, Millington JP, Arden NK, Latham JM. High failure rates with a large-diameter hybrid metal-on-metal total hip replacement: clinical, radiological and retrieval analysis. J Bone Joint Surg Br. 2011;93:608–615. CrossRef
- Bozic KJ, Kurtz S, Lau E, Ong K, Chiu V, Vail TP, Rubash HE, Berry DJ. The epidemiology of bearing surface usage in total hip arthroplasty in the United States. J Bone Joint Surg Am. 2009;91:1614–1620. CrossRef
- Brodner W, Bitzan P, Meisinger V, Kaider A, Gottsauner-Wolf F, Kotz R. Elevated serum cobalt with metal-on-metal articulating surfaces. J Bone Joint Surg Br. 1997;79:316–321. CrossRef
- Cuckler JM, Moore KD, Lombardi AV Jr, McPherson E, Emerson R. Large versus small femoral heads in metal-on-metal total hip arthroplasty. J Arthroplasty. 2004;19:41–44. CrossRef
- Davies AP, Willert HG, Campbell PA, Learmonth ID, Case CP. An unusual lymphocytic perivascular infiltration in tissues around contemporary metal-on-metal joint replacements. J Bone Joint Surg Am. 2005;87:18–27. CrossRef
- DePuy Orthopaedics Inc. DePuy ASR™ hip implant recall guide. 2011. Available at: http://www.depuy.com/usprofessional-depuy-hip-recall. Accessed June 29, 2011.
- De Smet K, De Haan R, Calistri A, Campbell PA, Ebramzadeh E, Pattyn C, Gill HS. Metal ion measurement as a diagnostic tool to identify problems with metal-on-metal hip resurfacing. J Bone Joint Surg Am. 2008;90(suppl 4):202–208. CrossRef
- Dunstan E, Ladon D, Whittingham-Jones P, Carrington R, Briggs TW. Chromosomal aberrations in the peripheral blood of patients with metal-on-metal hip bearings. J Bone Joint Surg Am. 2008;90:517–522. CrossRef
- Garbuz DS, Tanzer M, Greidanus NV, Masri BA, Duncan CP. The John Charnley Award. Metal-on-metal hip resurfacing versus large-diameter head metal-on-metal total hip arthroplasty: a randomized clinical trial. Clin Orthop Relat Res. 2010;468:318–325. CrossRef
- Hallab N, Merritt K, Jacobs JJ. Metal sensitivity in patients with orthopaedic implants. J Bone Joint Surg Am. 2001;83:428–436. CrossRef
- Heisel C, Streich N, Krachler M, Jakubowitz E, Kretzer JP. Characterization of the running-in period in total hip resurfacing arthroplasty: an in vivo and in vitro metal ion analysis. J Bone Joint Surg Am. 2008;90(suppl 3):125–133. CrossRef
- Jameson SS, Langton DJ, Nargol AV. Articular surface replacement of the hip: a prospective single-surgeon series. J Bone Joint Surg Br. 2010;92:28–37. CrossRef
- Korovessis P, Petsinis G, Repanti M, Repantis T. Metallosis after contemporary metal-on-metal total hip arthroplasty: five to nine-year follow-up. J Bone Joint Surg Am. 2006;88:1183–1191. CrossRef
- Ladon D, Doherty A, Newson R, Turner J, Bhamra M, Case CP. Changes in metal levels and chromosome aberrations in the peripheral blood of patients after metal-on-metal hip arthroplasty. J Arthroplasty. 2004;19:78–83. CrossRef
- Langton DJ, Jameson SS, Joyce TJ, Hallab NJ, Natu S, Nargol AV. Early failure of metal-on-metal bearings in hip resurfacing and large-diameter total hip replacement: a consequence of excess wear. J Bone Joint Surg Br. 2010;92:38–46. CrossRef
- Langton DJ, Jameson SS, Joyce TJ, Webb J, Nargol AV. The effect of component size and orientation on the concentrations of metal ions after resurfacing arthroplasty of the hip. J Bone Joint Surg Br. 2008;90:1143–1151.
- Langton DJ, Joyce TJ, Jameson SS, Lord J, Van Orsouw M, Holland JP, Nargol AV, De Smet KA. Adverse reaction to metal debris following hip resurfacing: the influence of component type, orientation and volumetric wear. J Bone Joint Surg Br. 2011;93:164–171. CrossRef
- Lavigne M, Belzile EL, Roy A, Morin F, Amzica T, Vendittoli PA. Comparison of whole-blood metal ion levels in four types of metal-on-metal large-diameter femoral head total hip arthroplasty: the potential influence of the adapter sleeve. J Bone Joint Surg Am. 2011;93(suppl 2):128–136. CrossRef
- Leslie I, Williams S, Brown C, Isaac G, Jin Z, Ingham E, Fisher J. Effect of bearing size on the long-term wear, wear debris, and ion levels of large diameter metal-on-metal hip replacements: an in vitro study. J Biomed Mater Res B Appl Biomater. 2008;87:163–172.
- Malviya A, Ramaskandhan J, Holland JP, Lingard EA. Metal-on-metal total hip arthroplasty. J Bone Joint Surg Am. 2010;92:1675–1683. CrossRef
- Matthies A, Underwood R, Cann P, Ilo K, Nawaz Z, Skinner J, Hart AJ. Retrieval analysis of 240 metal-on-metal hip components, comparing modular total hip replacement with hip resurfacing. J Bone Joint Surg Br. 2011;93:307–314. CrossRef
- McKee GK, Watson-Farrar J. Replacement of arthritic hips by the McKee-Farrar prosthesis. J Bone Joint Surg Br. 1966;48:245–259.
- Murray DW. The definition and measurement of acetabular orientation. J Bone Joint Surg Br. 1993;75:228–232.
- NJR Centre. National Joint Registry for England and Wales: 7th Annual Report, 2010. 2011. Available at: http://www.njrcentre.org.uk. Accessed June 29, 2011.
- Pandit H, Glyn-Jones S, McLardy-Smith P, Gundle R, Whitwell D, Gibbons CL, Ostlere S, Athanasou N, Gill HS, Murray DW. Pseudotumours associated with metal-on-metal hip resurfacings. J Bone Joint Surg Br. 2008;90:847–851. CrossRef
- Patel SR, Toms AP, Rehman JM, Wimhurst J. A reliability study of measurement tools available on standard picture archiving and communication system workstations for the evaluation of hip radiographs following arthroplasty. J Bone Joint Surg Am. 2011;93:1712–1719. CrossRef
- Pelt CE, Bergeson AG, Anderson LA, Stoddard GJ, Peters CL. Serum metal ion concentrations after unilateral vs bilateral large-head metal-on-metal primary total hip arthroplasty. J Arthroplasty. 2011;26:1494–1500. CrossRef
- Peters CL, McPherson E, Jackson JD, Erickson JA. Reduction in early dislocation rate with large-diameter femoral heads in primary total hip arthroplasty. J Arthroplasty. 2007;22:140–144. CrossRef
- Robb JE, Rymaszewski LA, Bentley HB, Donnan PT. Reliability of the acetabular teardrop as a landmark. Surg Radiol Anat. 1991;13:181–185. CrossRef
- Sabah SA, Mitchell AW, Henckel J, Sandison A, Skinner JA, Hart AJ. Magnetic resonance imaging findings in painful metal-on-metal hips: a prospective study. J Arthroplasty. 2011;26:71–76, 76.e1–2.
- Schmalzried TP, Peters PC, Maurer BT, Bragdon CR, Harris WH. Long-duration metal-on-metal total hip arthroplasties with low wear of the articulating surfaces. J Arthroplasty. 1996;11:322–331. CrossRef
- Smith TM, Berend KR, Lombardi AV, Jr., Emerson RH Jr, Mallory TH. Metal-on-metal total hip arthroplasty with large heads may prevent early dislocation. Clin Orthop Relat Res. 2005;441:137–142. CrossRef
- Steele GD, Fehring TK, Odum SM, Dennos AC, Nadaud MC. Early failure of Articular Surface Replacement XL total hip arthroplasty. J Arthroplasty. 2011;26(6 suppl):14–18. CrossRef
- Toms AP, Smith-Bateman C, Malcolm PN, Cahir J, Graves M. Optimization of metal artefact reduction (MAR) sequences for MRI of total hip prostheses. Clin Radiol. 2010;65:447–452. CrossRef
- Tower SS. Arthroprosthetic cobaltism: neurological and cardiac manifestations in two patients with metal-on-metal arthroplasty: a case report. J Bone Joint Surg Am. 2010;92:2847–2851. CrossRef
- US Food and Drug Administration. FDA’s role and activities. 2011. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241769.htm. Accessed June 29, 2011.
- Vendittoli PA, Amzica T, Roy AG, Lusignan D, Girard J, Lavigne M. Metal ion release with large-diameter metal-on-metal hip arthroplasty. J Arthroplasty. 2011;26:282–288. CrossRef
- Visuri TI, Pukkala E, Pulkkinen P, Paavolainen P. Cancer incidence and causes of death among total hip replacement patients: a review based on Nordic cohorts with a special emphasis on metal-on-metal bearings. Proc Inst Mech Eng H. 2006;220:399–407.
- Watters TS, Cardona DM, Menon KS, Vinson EN, Bolognesi MP, Dodd LG. Aseptic lymphocyte-dominated vasculitis-associated lesion: a clinicopathologic review of an underrecognized cause of prosthetic failure. Am J Clin Pathol. 2010;134:886–893. CrossRef
- Willert HG, Buchhorn GH, Fayyazi A, Flury R, Windler M, Koster G, Lohmann CH. Metal-on-metal bearings and hypersensitivity in patients with artificial hip joints: a clinical and histomorphological study. J Bone Joint Surg Am. 2005;87:28–36. CrossRef
- Zywiel MG, Sayeed SA, Johnson AJ, Schmalzried TP, Mont MA. State of the art in hard-on-hard bearings: how did we get here and what have we achieved? Expert Rev Med Devices. 2011;8:187–207. CrossRef
- The Withdrawn ASR™ THA and Hip Resurfacing Systems: How Have Our Patients Fared Over 1 to 6 Years?
Clinical Orthopaedics and Related Research®
Volume 471, Issue 2 , pp 430-438
- Cover Date
- Print ISSN
- Online ISSN
- Additional Links
- Industry Sectors
- Author Affiliations
- 1. Department of Orthopaedic Surgery, Duke University Medical Center, Box 3269, Durham, NC, 27710, USA
- 2. Department of Orthopaedic Surgery, University of California, San Francisco, San Francisco, CA, USA